PWS Lab Testing RFI.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Donor Collections Blood Testing

[Directorate of Clinical Support Services

Laboratory Departmement/Blood Donor Center Division

November 16, 2021

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide donor testing for the Blood Donor Center at NMRTC San Diego.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform donor testing the Blood Donor Center at NMRTC San Diego as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: Testing blood donors for transfusion transmissible infections (TTI) is a key component of the process of providing safe, pure, and potent blood products for NMRTC San Diego, in addition to the Department of Defense (DOD) in support of service men and women conducting operational missions around the world, military retirees, and dependent communities.

1.4 Objectives:

FDA-licensed blood typing, antibody screen, anti-hemmaglutinin titers (for Group O only), and FDA-approved transfusion-transmitted disease testing for all blood donors

Confirmatory testing as needed Vendor will provide transportation of specimens from San Diego Airport to Testing Site

1.5 Scope: To provide FDA-mandated blood donor testing for samples collected in support of volunteer blood and blood product donation.

1.6 Period of Performance (PoP): FY 25 plus 2 option years

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at Testing Site.

1.7.2 Recognized Federal holidays: Contractor is not required to perform services on holidays.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday or per normal operations except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for

November 16, 2021 the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.8 Contractor travel: Contractor shall be authorized travel expenses consistent with the cost principles and procedures in Federal Acquisition Regulation (FAR) Part 31.2, Travel Costs and the limitations of funds specified in this contract. All travel requires Government approval/authorization and notification to the Contracting Officer Representative (COR).

1.9 Other Direct Costs (ODC): Not applicable.

1.10 Quality

1.10.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. A comprehensive written QCP shall be submitted to the CO and COR within 5 working days when changes are made thereafter. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 7, Technical Exhibit 1 - CDRL A001.

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Contractor personnel

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. See process attached at Part 7 Section 7.1.1 of the PWS. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Offboarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx

1.11.2.2 The DHA’s contractor training instructions embedded at Part 7 Section 7.1.2.

(Government (DHA) requirements development staff must cut/paste onboarding checklist at https://info.health.mil/sites/DOP/OnboardingCtr/Contractor_OnBoarding_Checklist.pdf and embed most up-to-date form in Part 7, Section 7.1.2.)

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at:

https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note: Public Key Infrastructure (PKI)-restricted, printed versions available).

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use.

1.11.4 Key control: Reserved.

1.11.5 Lock combinations: Reserved.

1.12 Key personnel (Contractor): Not Applicable

1.13 Data rights: Reserved.

1.14 Reporting

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

1.14.2 Non-Disclosure Agreement (NDA): All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.14.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate

November 16, 2021 availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.15 Contractor Identification

1.15.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel.

Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.15.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order.

Contractor personnel shall make their contractor status known during introductions.

1.15.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system (If applicable, if not delete 1.16.1 and 1.16.2 and replace to 1.16 Reserved). Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.16.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC, or the COR must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated

November 16, 2021

March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.17.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

November 16, 2021

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D- Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R- Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.1.7 Insert additional Definitions here

FDA-licensed blood donor testing – the list of mandatory tests to be completed on all blood or blood product donations. The list of tests and acceptable testing methodology is listed on the FDA website at: https://www.fda.gov/vaccines-blood-biologics/blood-donor-screening

2.2 Acronyms:

AIS Automated Information System APL Approved Products List APL AQL Acceptable Quality Level ARRT Acquisition Requirements Roadmap Tool ATO Authority to Operate B2B Business-2-Business CAC Common Access Card

November 16, 2021

CAP Cloud Access Point CCEVS Common Criteria Cybersecurity Evaluation and Validation Scheme CDI Covered Defense Information CE Computer Environment CDRL Contract Data Requirement List CIO Chief Information Officer CJCSM Chairman of the Joint Chiefs of Staff Manual CMMC Cybersecurity Maturity Model Certification CMR Contractor Manpower Reporting CNSSI Committee on National Security Systems Instruction CO Contracting Officer(s) CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative CSP Cloud Service Provider CSSP Cyber Security Service Provider CUI Controlled Unclassified Information DAD-A Deputy Assistant Director for Acquisition DC3 DoD Cyber Crime Center DD Form 254 Department of Defense Contract Security Requirement List (if applicable) DB Design-Build DBB Design-Bid-Build DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DISA Defense Information System Agency DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DOT Department of Transportation DSAs Data Sharing Agreements DSAA Data Sharing Agreement Application DMZ Demilitarized Zone DoDM Department of Defense Manual DPCLO DHA Privacy and Civil Liberties Office DUA Data Use Agreement eMSM Enhanced Multi-Service Markets EULA End User License Agreement EVM Earned Value Management FAR Federal Acquisition Regulation FCI Federal contract information FDA Food and Drug Administration FE Facilities Enterprise FedRAMP Federal Risk Authorization and Management Program FISMA Federal Information Security Modernization Act FRCS Facility Related Control Systems FSO Facilities Security Officer

November 16, 2021

HA Health Affairs HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity HIT Health Information Technology IATA International Air Transport Association IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting I/O In/Out Processing Portal IPv Internet Protocol Version IS Information System ISP Internet Service Provider IT Information Technology ISCM Information Security Continuous Monitoring IV&V Independent Verification & Validation MedCOI Medical Community of Interest MHS Military Health System MIL-STD Military Standard MTFs Military Treatment Facilities NCR National Capitol Region NDA Non-Disclosure Agreement NIAP National Information Assurance Partnership NIST National Institute of Standards and Technology OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPM Office of Personal Management OSD Office of the Secretary of Defense P-ATO Personal Authorization to Operate P&R Personnel and Readiness PGI Procedures, Guidance and Information PDT Project Delivery Team PHI Protected Health Information PII Personally Identifiable Information PIT Platform Information Technology PK Public Key PKI Public Key Infrastructure POA&M Plan of Action and Milestones POC Point of Contact PMO Program Management Office PoP Period of Performance PP Personal Property PPSM Ports, Protocols, and Services Management PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance

November 16, 2021

QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFP Request for Proposal RFQ Request for Quotation RMF Risk Management Framework SP Special Publication SPRS Supplier Performance Risk System SRM Sustainment, Restoration and Modernization SRG Security Requirements Guides STIG Security Technical Implementation Guides TOS Terms of Service TTI Transfusion-Transmitted Infections US United States UFC Unified Facilities Criteria VPN Virtual Private Network XML Extensible Markup Language

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

2.3.1 DODI 6480.04 – Armed Services Blood Program

2.3.2 OPNAVINST 6530.4B – Department of the Navy Blood Program

November 16, 2021

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below:

3.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below:

3.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below:

3.4.1 Procurement Integrated Enterprise (PIEE), GFP Module Application The contractor shall be responsible for obtaining and maintaining access, training and successful operation of the PIEE/GFP Module application for the entirety of the contract/task order PoP.

The PIEE GFP Module application is located at the following website: https://wawf.eb.mil/piee-landing/. Access to PIEE/GFP Module application training materials and in-depth information applicable to the contractor’s responsibilities regarding GFP can be found at the following website: https://dodprocurementtoolbox.com/.

Contracting Office Responsibilities:

The Contracting Office shall ensure close coordination and validation of the GFP items with the COR and DHA Accountable Property Officer prior to uploading the GFP Attachment into the PIEE/GFP Module. At the time GFP is anticipated and identified, the Government will upload the GFP Attachment into the PIEE/GFP Module. It is the Contracting Office’s responsibility to prepare, upload and maintain the GFP Attachment in the PIEE/GFP Module in accordance with the GFP Attachment instructions provided at the DoD Procurement Toolbox. The CO and COR shall manage and keep an inventory of any GFP associated with contract/task orders awarded through DHA, in accordance with applicable FAR Part 45, DoD FAR Supplement (DFARS) 245 with respective clauses, DHA AI 095 and PD 45-01 following the change in disposition of items listed on that PIEE/GFP Module Attachment.

The contracting office will also review, acknowledge, reject and/or approve shipment orders provided by the contractor as appropriate. Functional roles can be determined within the Contracting Office, and requested within the PIEE/GFP Module system.

Contractor Responsibilities:

A key contractor responsibility is to work with the CO and COR to ensure the PIEE/GFP Module data, to include the PIEE/GFP Attachment, provides a timely, complete and accurate accounting of the GFP applicable to the contract/task order. Contractors are required to report the receipt of any GFP shipped to them, regardless of whether it is listed on the GFP Attachment for their contract. Similarly, contractors are required to utilize the GFP Module application in conjunction with the shipment of GFP to the Government, or in reporting Property Loss of GFP issued (such as destruction or loss). Discrepancies or disputes regarding property shipped to or shipped from the contractor must be reported via the GFP Module application, with the CO having authority over final designation of status.

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

November 16, 2021

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders.

These Services are described below:

4.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

4.3 Secret Facility Clearance: Not applicable.

4.4 Materials: IATA/DOT-compliant shipping containers, external labels, and fillable shipping manifest documentation (as required by contractor).

4.5 Equipment: Not applicable.

4.6 Facilities: Not applicable.

November 16, 2021

PART 5

5.0 SPECIFIC TASKS

5.1 Requirements:

Specimen Testing:

a. Using Food and Drug Administration approved methodologies for testing blood donations, Vendor must provide accurate testing of received specimens in accordance with facility guidelines.

b. Vendor will deliver test results the NMCSD Blood Donor Center via email no later than 1300 the day following receipt of the donor specimens. In the event an email option is not functioning, the Vendor will fax test results in an easy to read format.

c. Vendor must maintain licensure by the Food and Drug Administration and ensure all test methods employed are approved by the FDA for use in blood donation testing.

d. Vendor will immediately notify the NMCSD Blood Donor Center of any delays or inability to transport donor specimens to the testing facility.

e. Vendor will provide all required facilities, personnel, services, equipment, and supplies to provide blood donor testing services to deliver interrupted performance of donor testing.

f. Vendor will maintain all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations.

g. Vendor will guarantee any subcontractors performing services hereunder shall meet the same requirements and any applicable State requirements. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be made available upon request.

f. Vendor will verify all employees perform duties in accordance with their level of license and certification. Vendor will ensure all testing staff complies with the minimum Federal, State, and local law qualifications/requirements.

g. Vendor will ensure each referral laboratory possesses all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations.

h. Vendor will provide all necessary instructions for sample submission, paperwork required for sample submission, transport boxes, coolant devices, and packaging materials.

i. Vendor will provide results for the following donor testing:

Anti-HIV-1/2, Anti-HTLV-I/II, Anti-HBsAg, Anti-HCV, Anti-HBc, HIV/HCV/HBV NAT (Pool), WNV (Pool), ABO/Rh, AB Screen, Syphilis, CMV

Anti-A, Anti-B Antibody Titers, ≤ 1:256 depending on methodology

j. Vendor will ensure all confirmatory and/or supplemental testing is performed within 28 days upon receipt for the following tests:

Hepatitis B Surface Antigen (EIA) Hepatitis B Virus Core (EIA) Human T- Lymphotropic Viruses Type I & II (HTLV 1/11) (EIA) Human Immunodeficiency Virus (EIA/NAT) Hepatitis C Virus (EIA/NAT) Treponema pallidum (Syphilis) Hepatitis C Virus

k. Vendor will ensure the accurate and timely performance of laboratory testing services. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions as established by accrediting and licensing agencies.

l. Vendor will notify the NMCSD Blood Donor Center of improper specimen submission and rejection. Notification of rejected samples/shipments will be sent electronically to the current points of contacts provided by the customer.

m. Vendor will communicate testing errors or discrepancies to the attention of the representatives of the blood donor center immediately upon discovery.

4. Hours of Operation:

a. Vendor must be available by telephone every working day from Monday through Sunday during the business hours of 0730-1700 in accordance with the NMCSD BDC blood drive schedule.

5. Transportation of Specimens to Testing Facility:

a. NMCSD BDC will provide transportation of samples to San Diego International Airport Air Cargo facilities for transport by vendor’s contracted shipping partner. Vendor must provide specimen pick-up at the destination facility for transportation to the testing facility.

b. If offering door-to-door services, the Vendor’s Specimen Transport driver must contact the NMCSD BDC at (619) 532-6655 upon arrival at Naval Base San Diego to receive the specimen shipment. Cancellation of transport of specimens must be made by the NMCSD BDC no later than 1200 on the same day of the scheduled pick up.

c. Vendor must ensure cold chain requirements and integrity of the specimens is maintained from during the entirety of transport to the testing facility.

HLA 1,2 for TRALI mitigation West Nile Virus (IDS) Babesia (IDT or Pooled) T. cruzi antibody (Chagas) Confirmatory testing as required

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6. Technical Support:

a. Telephone support for technical and operational questions must be available every day of the week from Monday through Sunday during the business hours of 0730-1700.

b. The Vendor must have an information technology technician available to assist with maintaining, repairing, troubleshooting, and training on the testing computer information system.

PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement from Part 5)

PWS Reference Acceptable Quality Level (AQL) (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of Surveillance

Performance Requirements Summary (PRS) # 1.

The contractor shall provide testing results by email no later than 1300 on the day after samples are received, and no later than 24 hours after collection.

PWS Part 5, Section 5.1 95% of the time 100% inspection at the

MTF.

Performance Requirements Summary (PRS) #2 The contractor shall notify the NMCSD BDC of any delays in reporting routine testing results.

PWS Part 5, Section 5.1 98% of the time 100% inspection at the

MTF.

Performance Requirements Summary (PRS) #3 The contractor will maintain FDA-licensure and other applicable accreditations throughout the period of the contract.

PWS Part 5, Section 5.1 100% of the time 100% inspection at the

MTF.

Performance Requirements Summary (PRS) #4 The contractor will perform or send-out to a reference lab any confirmatory testing as required by Federal regulation or by DOD-mandated blood donor testing standards. Status of testing will be reported to the NMCSD BDC as soon as confirmatory testing is indicated.

PWS Part 5, Section 5.1 100% of the time 100% inspection at the

MTF.

November 16, 2021

PART 7, TECHNICAL EXHIBIT 1

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

CDRL A001 –

Quality Control Plan

CDRL 1 Quality Plan

Within 30 days of task order award

Contractors discretion

CDRL A001 to CO All, See PWS 1.10.1